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Experiences

Current Experience

  • Manager Clinical Operations
    Since November 2012
    Management of a team of Clinical Operations: - defining staff individual objectives and training plans - performing staff yearly evaluations - checking of correct use of timesheet application and approval of the hours including holiday requests - providing support to the professional development of less experienced staff - developing and maintaining good internal communication - interviewing candidates - Managing the resources needs and people allocation Follow-up of all projects performed on behalf of the sponsor by 4Clinics: - being the main contact for all aspects of the project and communicating about the project with the sponsor as needed - participating in the preparation of meetings with the sponsor - ensuring the respect of project deadlines - performing quality control - ensuring the quality and validity of the deliverable contents Support to 4Clinics sales: - understanding the needs of 4Clinics clients and addressing their needs adequately - writing answers to proposal for Clinical Operations tasks and evaluating the associated costs - providing technical support to the sales during meetings with clients Creation of internal standards and recommendations regarding Clinical Operations tasks: - defining working process - writing SOPs and guidance’s - ensuring the compliance of all procedures and study deliverables with 4Clinics standards

Past Experience

  • Clinical Specialist
    July 2013 --- June 2015
    Clinical Quality management: writing and reviewing SOP, study documents (e.g. Protocol, Study Manual, Monitoring Plan), newsletter, recruiting material, communication plans Ad Interim: clinical manager (supervision of clinical activities; meeting with Steering Committee; Team calls and 3rd parties calls: leading and minutes) DSMB meetings: organize, minutes and follow up CRF: review, update, follow up closely with Data Management TMF: guidance and update of SOP Tracking systems: creation of investigator payments tracker Verification financial agreements KPI

  • Clinical Development Manager
    February 2012 --- August 2012
    Management of outsourcing activities for CRA, CTA, clinical project manager: Recruitment of consultants, Customer relations, Missions follow up, Annual assessments, Training plans definition Trade activities: Canvassing, Participation commercial presentations, Involvement in events (congress, symposium, networking…) Management of in-house CRA: annual assessments, training plans, recruitment Request for proposal management Organization of trainings Account management: Relationship procurement, Contracts and invoicing management Transversal activities: Animation of workgroups, Animation of meetings Respect of quality commitments Participating in the continual improvement of the Quality System Identifying and to record non conformities

  • Clinical Project Manager
    November 2006 --- January 2012
    From November 2006 until October 2010 I worked in consulting in a pharmaceutical company. From October 2010 until January 2012 I worked as project manager in-house at MSOURCE During pregnancy leave of a colleague I also worked as a clinical research manager in-house at MSOURCE (from October 2010 until March 2011)

  • Clinical Research Associate (CRA)
    July 2004 --- November 2006

  • Clinical Project Assistant
    March 2001 --- July 2004

Personality

Self Assessment :
CommunicativeCreative thinkingProblem solvingFlexibilityCuriosityProactivity

Knowledge

BrightOwl Assessment :
Team BuildingTeam LeadershipTeam ManagementInternational Project ManagementProject CoordinationProject ManagementProject PlanningQuality Assurance (QA)QA complianceQuality AuditingQuality ManagementCoachingPhases of clinical development (phase I to IV)
LinkedIn Assessment :
Clinical monitoringICH-GCPClinical trialsClinical researchClinical trial management

Skills and Expertise

BrightOwl Assessment :
Coach and provide guidance to clinical staff.Coach staffCoach clinical staffCoachGuide staffCollaborate with project teamLead teamsWork collaboratively with the other members of the clinical research team Work with coordination and data management teamsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Coordinate projectsCreate clinical project documents according to the protocolFollow up projectsManage multiple projectsManage projects resourcesCalculate timelines for conducting and completing the trialDevelop study timelinesManage study budget
Self Assessment :
Communicate with investigatorCommunicate with sponsorCalculate trial timelinesDevelop study timelinesManage study budgetManage vendor budgets Build and manage the Trial Master File (TMF)Design trial master file (TMF)Manage Clinical Trial Management System (CTMS) Patient recruitment

Education

  • Bachelor in Physiotherapy from Katholieke Hogeschool Brussel in 2000

Training and Certification

  • Prince2 in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Full Proficiency

Area / Region

Opwijk, Belgium

Others

Driving License
  • No